other material
confidence high
sentiment positive
materiality 0.60
MIRA Pharmaceuticals starts MAD Phase 1 of oral Ketamir-2; selects CIPN for Phase 2a
MIRA PHARMACEUTICALS, INC.
- Initiated multiple ascending dose (MAD) portion of Phase 1 trial for oral Ketamir-2 in healthy volunteers.
- Selected chemotherapy-induced peripheral neuropathy (CIPN) as lead indication for planned Phase 2a study.
- In SAD portion, no serious or dose-limiting adverse events; no clinically significant safety concerns.
- Ketamir-2 is a non-scheduled oral analog of ketamine designed for once-daily dosing without psychoactive effects.
- Preclinical data showed Ketamir-2 outperformed ketamine, gabapentin, and pregabalin in neuropathic pain models.